Israel

This agreement recognises Israel’s industrial standards as being equivalent to European standards. It covers products for human and veterinary use (medicinal products, active pharmaceutical ingredients and excipients) and procedures related to good manufacturing practice (GMP).

The agreement means that Israel and the EU recognise each other's:

GMP inspection conclusions;

manufacturing and import authorisations;

certification of conformity of batches, without the need for re-testing at import;

official-control-authority batch release (OCABR).

Under the terms of the agreement, Israel can participate in networks and meetings, including:

EudraGMDP;

the Official Medicines Control Laboratories network;

GMP and Good Distribution Practice (GDP) Inspectors Working Group meetings;